MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT MC1610 manufactured by Bard Peripheral Vascular, Inc..
[185736204]
A voluntary recall was issued for the max-core disposable core biopsy instrument for specific product code/lot number combinations. The affected product code/lot number combinations may be at risk of having firing issues. An example of a firing issue is where the device does not completely fire, resulting in the inability to obtain tissue samples. A root cause investigation and field action determination was conducted as a result of an increase in complaints for failure to fire, firing problem, and failure to obtain samples. The investigation included an extensive manufacturing review, risk documentation review for the three reported malfunctions, and evaluations performed on the returned devices. The root cause for the increase in complaints was related to mold maintenance that was performed on the cannula over-mold for mold 3. That maintenance had the unintended consequence of impacting product performance in specific low frequency use situations. The change made to mold 3 increased the spacing between the locking and unlocking mechanisms of the device, resulting in a reduction in stored energy within the device. This, in combination with the density of the tissue being biopsied, can occasionally result in issues where the device does not fully fire when the trigger is pressed (i. E. Only the stylet fires). All lots manufactured after the maintenance on mold 3 was performed are included in the scope of the recall. All reported complaints from the affected product code/lot number combinations that are possibly related to the firing issue have been classified as failure to fire, firing problem, or failure to obtain samples. This reported complaint is from an affected lot number that was reported for one of these firing issues. Expiry date (12/2021).
Patient Sequence No: 1, Text Type: N, H10
[185736205]
It was reported that during an ultrasound guided kidney biopsy through normal density tissue, the device allegedly failed to fire. No coaxial needle was used. The procedure was completed using another device. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-02127 |
| MDR Report Key | 9889733 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-15 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | KNW |
| Date Received | 2020-03-27 |
| Model Number | MC1610 |
| Catalog Number | MC1610 |
| Lot Number | REDN3426 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |