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

Model Number	CQ7588
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.
Event or Problem Description
It was reported that during an angioplasty procedure the pta balloon allegedly got stuck inside the introducer sheath during retraction.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the device returned stuck in the user's introducer sheath.The balloon material was bunched at the distal tip, and the distal tip of the sheath was flared, indicating retraction issues.Additionally, a complete break in the outer catheter shaft was noted just proximal to the proximal balloon joint; the inner guidewire lumen was intact.Therefore, the investigation is confirmed for the reported retraction issues, as well as for a break in the catheter shaft.It is likely retraction issues led to the catheter break.However, the definitive root cause for the retraction issue could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.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.(expiry date: 03/2021).
Event or Problem Description
It was reported that during an angioplasty procedure the pta balloon allegedly got stuck inside the introducer sheath during retraction.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the device returned stuck in the user's introducer sheath.The balloon material was bunched at the distal tip, and the distal tip of the sheath was flared, indicating retraction issues.Additionally, a complete break in the outer catheter shaft was noted just proximal to the proximal balloon joint; the inner guidewire lumen was intact.Therefore, the investigation is confirmed for the reported retraction issues, as well as for a break in the catheter shaft.It is likely retraction issues led to the catheter break.However, the definitive root cause for the retraction issue could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.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.(expiry date: 03/2021).
Event or Problem Description
It was reported that during an angioplasty procedure the pta balloon allegedly got stuck inside the introducer sheath during retraction.There was no reported patient injury.

• 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: 8086495
• Report Number: 2020394-2018-02070
• Device Sequence Number: 1345972
• Product Code: DQY
• UDI-Device Identifier: 00801741063138
• UDI-Public: (01)00801741063138
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2019

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 Model Number: CQ7588
• Device Catalogue Number: CQ7588
• Device Lot Number: RECR1791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 02/12/2019; 02/04/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 02/14/2019; 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1