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

Model Number	CQ5054
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that upon opening of the outer packaging, the device was allegedly found without the inner packaging.Another device was used to complete the procedure.There was no patient involvement.
Additional Manufacturer Narrative
Manufacturing review: manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.Investigation summary: the device and outer packaging sleeve were returned for evaluation.A visual inspection found the outer sleeve showing signs of it being previously opened.It was noted that the inner storage tube was returned in the outer sleeve with the distal end of the tube at the top of the sleeve.This indicated that the tube had been removed from the sleeve prior to return.The storage tube was not returned in the sterile inner pouch, and the pouch was not returned for evaluation.Slight damage to the outer sleeve and inner storage tube was noted, however, no damage was noted to the device.Although the device packaging was returned without the inner pouch, the investigation is inconclusive for the alleged lack of the inner pouch as the device was returned opened with signs of the device being removed from the outer sleeve prior to return.No information was provided that could confirm the device was shipped without an inner sterile sleeve.Per the packaging procedure for this device, the assembly operator inspects each inner pouch prior to inserting into the outer sleeve.Therefore, it is unlikely that the reported issue is manufacturing related.The definitive root cause for the reported missing inner pouch could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11: b5, h3, h6 (results1, conclusion1).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 upon opening of the outer packaging, the device was allegedly found without the inner packaging.It was further reported that another device was used to complete the procedure.There was no patient involvement.

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8340291
• Report Number: 2020394-2019-00128
• Device Sequence Number: 1774829
• Product Code: DQY
• UDI-Device Identifier: 00801741062803
• UDI-Public: (01)00801741062803
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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 Expiration Date: 04/30/2021
• Device Model Number: CQ5054
• Device Catalogue Number: CQ5054
• Device Lot Number: RECS0398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 45