20/30 PRIORITY PACK 1000186

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for 20/30 PRIORITY PACK 1000186 manufactured by Abbott Vascular.

Event Text Entries

[186376312] The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10

[186376313] It was reported that the procedure was to treat a mildly calcified, mildly tortuous lesion in the left anterior descending (lad) artery. A balloon catheter was advanced to the lesion and an attempt was made to inflate the balloon; however, the indeflator could only be pressurized to 6 atmospheres (atm) and would not inflate any further after that. There was no adverse patient effect or a clinically significant delay in the procedure. Another indeflator was used to successfully complete the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5

[188933521] The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents from this lot. As the device was not returned for analysis. The investigation determined a conclusive cause for the reported difficulties cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

Report Number2024168-2020-03186
MDR Report Key9908636
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-10-10
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 2024168
Manufacturer Street26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name20/30 PRIORITY PACK
Generic NameINDEFLATOR PPAK 20/30
Product CodeMAV
Date Received2020-03-31
Model Number1000186
Catalog Number1000186
Lot Number60209836
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patient NumberTreatmentOutcomeDate
10 2020-03-31

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.