PALMAZ-SCHATZ BALLOON-EXPANDABLE WITH DELIVERY SYSTEM PS1530

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1997-08-28 for PALMAZ-SCHATZ BALLOON-EXPANDABLE WITH DELIVERY SYSTEM PS1530 manufactured by Cordis.

Event Text Entries

[91067] Limited left heart catheterization was performed from the right femoral artery utilizing 8f left 3. 5 xb guiding catheter, 0. 014" x 300cm stabilizer wire and 2. 5mm predator balloon. An intermediate o. O14" wire and a 2. 5 predator balloon and advanced to the lad and several attempts were made to cross the lesion. This was unsuccessful and a standard wire was also tired without success. Co then procedded to dilate the ostium of the second diagonal using several inflations, maximum up to 9 atmospheres for 45 seconds. With each inflation, the pt had angina, but no signicant st elevations. An adequate result appeared to be obtained and the pt was prepared to transferred to the ccu for further management. Before leaving the cath table, he developed recurrent angina and had repeated coronary angiography and this showed that there was recoil slightly sluggish flow down the diagonal branch. Hcp then advanced a 0. 014" x 300cm extra support stabilizer wire and using a 3. 0mm titan balloon, one inflation was performed up to 6 atmospheres for 45+ seconds. This gave an excellent channel and hcp then proceeded to insert a 3. 0 x 15mm j&j stent. The advancement to the diagonal was easy and straight forward, however deployment took place in the diagonal and the proximal half in the lad. However, it was noted that on deflating the balloon, the balloons simultaneouly came back to the mid lad. The balloon was again advanced into the stent and another inflation was performed, 4 and 6 atmospheres. The stent balloon was taken out and a 3. 0mm titan 18 balloon was then advanced with the idea of performing high pressure inflation. The balloon, however, would not cross into the diagonal branch and a brief inflation in the proximal half of the stent was performed. It was then noted that the wire was stuck in the stent and would not move. Great care was taken while exchanging the stent balloon for the titan 18 balloon and the wire remained in the distal d. With some force, however, the wire together with the stent were removed en-block. The pt remianed stable and repeat angiography revealed that the second diagonal was still widely patent with excellent flow. The distal lad remianed occluded. The directions for use, which accompany each device, recommend to the user that a stent not be utilized for ostial lesions or lesions located at a bifurcation. At the time of this report, the product upon which this medwatch is based has not been returned for evaluation. Should the product become available, a follow-up 3500a report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2247023-1997-00265
MDR Report Key117141
Report Source05,06,07
Date Received1997-08-28
Date of Report1997-07-02
Date of Event1997-06-12
Date Facility Aware1997-06-12
Report Date1997-07-02
Date Reported to Mfgr1997-07-02
Date Mfgr Received1997-07-02
Device Manufacturer Date1997-05-01
Date Added to Maude1997-09-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePALMAZ-SCHATZ BALLOON-EXPANDABLE WITH DELIVERY SYSTEM
Generic NameCORONARY STENT WITH DELIVERY SYSTEM
Product CodeMAF
Date Received1997-08-28
Model NumberNA
Catalog NumberPS1530
Lot Number132970
ID NumberNA
Device Expiration Date1998-11-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1.5 MO
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key114886
ManufacturerCORDIS
Manufacturer Address40 TECHNOLOGY DRIVE WARREN NJ 07059 US
Baseline Brand NamePALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Baseline Generic NameCORONARY STENT WITH DELIVERY SYSTEM
Baseline Model NoNA
Baseline Catalog NoPS1530
Baseline IDNA
Baseline Device FamilyCORONARY STENT WITH DELIVERY SYSTEM
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]18
Baseline PMA FlagY
Premarket ApprovalP9000
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1997-08-28

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