MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RIVAL; PTA BALLOON DILATATION CATHETER

Model Number	RV13586
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an angioplasty procedure in the lower extremities, the balloon shaft allegedly ruptured.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 08/2024).
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Three photos were reviewed.All the three photos show two detached segments of the catheter and balloon; the first segment consists of detached balloon, which is stored within the balloon protector and stylet still loaded at the distal tip; distal end of balloon catheter noted to be stretched.The second segment consists of the remaining portion of the catheter, which is noted to be stretched at the distal end.No other anomalies were noted.Therefore, based on the photo review, the reported detachment was confirmed.Therefore, the investigation was confirmed for the reported detachment as the photos shows the detached balloon and catheter in two segments.A definitive root cause for the reported detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 08/2024), g3, h6(method).H11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that prior to an angioplasty procedure in the lower extremities, the balloon shaft allegedly ruptured.The procedure was completed using another device.There was no patient contact.

• Brand Name: RIVAL
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14139783
• Report Number: 2020394-2022-00301
• Device Sequence Number: 3986504
• Product Code: DQY
• UDI-Device Identifier: 00801741063947
• UDI-Public: (01)00801741063947
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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 Model Number: RV13586
• Device Catalogue Number: RV13586
• Device Lot Number: GFFW0194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 67 KG