MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER

Catalog Number	0184511
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that upon removing the device from the protective sheath an alleged hole was observed near mid-shaft of the balloon catheter.Another balloon was used to perform the procedure.There was no reported patient contact.
Additional Manufacturer Narrative
The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: the sample appears to be clean.The balloon size for this product is printed on the balloon hub of the catheter and identified the return sample as a 18 mm x 4.5 cm.No holes or catheter damage was identified.No anomalies were noted to the device.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035" guidewire and it passed without issue.The balloon was inflated to nominal pressure and rbp without issues.The balloon then deflated without issues.This test was repeated two additional times, which were both successful.No leaks or any other issues were identified.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned.The complaint investigation is unconfirmed for hole in material, as the sample inflated without issue during functional testing and no holes were identified.The definitive root cause could not be determined based upon the available information.It is unknown if procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: precautions: - carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.- in order to activate the hydrophilic coating, it is recommended to wet the ultraverse catheter with sterile saline solution immediately prior to its insertion in the body.Dilatation catheter preparation: - remove catheter from package.Verify the balloon size is suitable for the procedure and the selected accessories accommodate the catheter as labeled.- remove the balloon guard and stylet by grasping the balloon catheter just proximal to the balloon and with the other hand, gently grasp the balloon protector and slide distally off of the balloon catheter.- in order to activate the coating, wet the balloon catheter with sterile saline immediately prior to its insertion into the introducer sheath.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that upon removing the device from the protective sheath an alleged hole was observed near mid-shaft of the balloon catheter.Another balloon was used to perform the procedure.There was no reported patient contact.

• Brand Name: TRUE DILATATION CATHETER
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6362730
• Report Number: 2020394-2017-00118
• Device Sequence Number: 13668333
• Product Code: OZT
• UDI-Device Identifier: 00801741097430
• UDI-Public: (01)00801741097430
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0184511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1