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

Catalog Number	PTA5-35-80-4-8.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The device was advanced ipsilaterally to the middle of the sfa.When the balloon was inflated nearly at the rated burst pressure, it ruptured.(it cannot be determined in which direction, circumferential or longitudinally, the balloon ruptured) another manufacturer's device was used instead to complete the procedure.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Initial reporter postal code: (b)(6).Dept: cardiovascular internal medicine.(b)(4).(additional information provided/updated): investigation/evaluation during the course of the investigation, a review of the complaint history, quality control, device history record, specifications, documentation, instructions for use (ifu), and drawings of the product was conducted.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There was not any evidence to suggest the product was not made to specifications.There were no non conformances or re-works logged by quality control against the lot.Each device is shipped with an ifu which states the appropriate uses, contraindications, warnings and precautions, and proper usage procedures including proper inflation and deflation procedures.The ifu states: do not exceed rated burst pressure and do not use a power injector for balloon inflation or injection of contrast medium as rupture may occur.The ifu also states, if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.The nominal inflation for this device is 10 atm and the rated burst pressure is 15 atm.It is unclear what pressure the balloon was inflated to before rupture.Details regarding removal of the device were not provided.The device is designed to burst linearly.However, a balloon may burst or tear circumferentially due to angulation or calcification.Calcifications can have unexpected sharp protrusions which can damage the balloon and contribute to burst or tear.Patient anatomy in this event is unknown.It is unknown whether the balloon ruptured longitudinally or circumferentially.A definitive root cause could not be identified.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
The device was advanced ipsilaterally to the middle of the sfa.When the balloon was inflated nearly at the rated burst pressure, it ruptured.(it cannot be determined in which direction, circumferential or longitudinally).Another manufacturer's device was used instead to complete the procedure.There have been no adverse effects to the patient reported.

• 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: 5651351
• Report Number: 1820334-2016-00308
• Device Sequence Number: 18884081
• Product Code: DQY
• UDI-Device Identifier: 10827002523330
• UDI-Public: (01)10827002523330(17)180114(10)5577564
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2016

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 Catalogue Number: PTA5-35-80-4-8.0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/21/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2016
• Supplement Report FDA Received Date: 10/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1