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

Model Number RV13556

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2022).

Event Description

It was reported that prior to the angioplasty procedure, the package of the device allegedly opened with a split.It was further reported that the sterile part was exposed externally.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one rival pta catheter was returned for evaluation.The sample was in its original packaging.A tear was noted to the inner packaging of the device, located in the top and centered of the inner pouch.No other anomalies noted to the sample.No functional testing was performed due to the nature of the complaint.5 electronic photos were also provided for review.Photos 1-3 shows the inner packaging sleeve of the device.A tear can be noted to the inner sleeve near the device hanging tab.Photos 4-5 show the product labeling and outer box.The lot and catalog number match the reported information in system.Therefore, based on the return sample analysis and photo review the reported packaging tear can be confirmed.A definitive root cause for the inner packaging tear could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 10/2022).H11: section a through f ¿ the information provide by bd represents all 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 Description

It was reported that prior to the angioplasty procedure, the package of the device allegedly opened with a split.It was further reported that the sterile part was exposed externally.There was no patient contact.

• Brand Name: RIVAL PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10948505
• MDR Text Key: 219953817
• Report Number: 2020394-2020-20754
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063527
• UDI-Public: (01)00801741063527
• Combination Product (y/n): N
• PMA/PMN Number: K120722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RV13556
• Device Catalogue Number: RV13556
• Device Lot Number: GFDW3546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other