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

Model Number	G52255
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/15/2018
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 upon opening the package, the advance 35 lp low profile balloon catheter was observed to be broken.The device did not come into contact with a patient.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, quality control, and a visual inspection of the returned device were conducted during the investigation.One advance 35lp low profile balloon catheter (pta5-35-135-4-12.0) was returned for evaluation.The spiral holder or outer packaging were not present.The catheter is separated at 121.4cm from the proximal end.The distal section is 13.6cm in length.The separation is 6mm proximal to the proximal balloon bond.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Additionally, 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 showed 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, the examination of the returned product, 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.

• 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: 7195959
• Report Number: 1820334-2018-00175
• Device Sequence Number: 16610238
• Product Code: DQY
• UDI-Device Identifier: 10827002522555
• UDI-Public: (01)10827002522555(17)200727(10)8098262
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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 Model Number: G52255
• Device Catalogue Number: PTA5-35-135-4-12.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1