MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTA5-35-80-5-4.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during a superficial femoral artery (sfa) case on an unspecified date, upon approach of the lesion and during inflation the advance 35 lp low profile balloon catheter circumferentially ruptured.This occurred prior to the nominal diameter being reached.Given the tight stenosis, the distal remnant of the balloon could not be retrieved and therefore a stent was deployed to support patency of the vessel as well as preventing distal emboli complications.Another manufacturer's balloon was used to post-dilate the stent.No information was provided regarding calcification or tortuosity of the vessel.Stent size was not provided.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Although requested, additional information has not been provided.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation.A review of the dimensional verification, complaint history, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that it was separated in two pieces, with the distal tip and distal balloon portion neither present nor attached.The portion of the balloon which was returned did appear to rupture circumferentially.Three portions of the catheter were damaged and appeared flattened.No additional damage was noted on the returned device.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7882601
• Report Number: 1820334-2018-02690
• Device Sequence Number: 19419934
• Product Code: DQY
• UDI-Device Identifier: 10827002523385
• UDI-Public: (01)10827002523385(17)190921(10)7292009
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091527
• 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): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2019
• Device Catalogue Number: PTA5-35-80-5-4.0
• Device Lot Number: 7292009
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BARD CONQUEST BALLOON; BARD CONQUEST BALLOON
• Outcome Attributed to Adverse Event: Required Intervention