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

Catalog Number	PTA5-35-80-5-6.0
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that after successful completion of an abdomen with runoff procedure, the advance 35 lp low profile balloon catheter snapped in two upon removal of the balloon from the patient.A portion of the catheter remained within the patient's anatomy and was able to be pulled out.A wire guide (manufacturer unspecified) was in place upon removal of the catheter; another manufacturer's 6 french (fr) sheath was utilized during the procedure.The balloon was allowed to return to ambient pressure once deflated.The lesion was located in the patient's common femoral artery; angulation and calcification were present.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.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.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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: 7334004
• Report Number: 1820334-2018-00743
• Device Sequence Number: 278434
• Product Code: DQY
• UDI-Device Identifier: 10827002523392
• UDI-Public: (01)10827002523392(17)200408(10)7814872
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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: PTA5-35-80-5-6.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 07/11/2018
• 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: ARROW SHEATH 6FRWIRE GUIDE (UNSPECIFIED); ARROW SHEATH 6FRWIRE GUIDE (UNSPECIFIED)
• Patient Age: 82 YR