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

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A hair was found in the sterile packaging of an advance 35 lp low profile balloon catheter.There was no patient involvement.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One sealed unused advance 35 lp low profile balloon catheter was returned for investigation.A hair like fiber was noted in the bottom left corner of sealed package.The fiber is 1.7 centimeters (cm) in length.No damage was noted to the package.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per manufacturing quality control documentation, "inspect all sections 100%, unless otherwise specified.Verify if visible inner package (if applicable) is sealed.Inspect all package seals (end seals, side seals and chevron seal if applicable).Examine each seal for defects, foreign matter (dirt, hair, paper, burnt seals, fuzz, and etcetera).Ensure each seal is completely solid, smooth and free from wrinkles.Examine entire package for defects.Reject package if it contains any visible cuts, holes or foreign matter (dirt, hair, paper, fuzz, and etcetera)." based on the information provided, examination of the returned product, and the results of our investigation, the root cause for this event was determined to be manufacturing related.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 6894968
• Report Number: 1820334-2017-03362
• Device Sequence Number: 699429
• Product Code: DQY
• UDI-Device Identifier: 10827002523453
• UDI-Public: (01)10827002523453(17)200310(10)7741537
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2017

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: N/A
• Device Catalogue Number: PTA5-35-80-6-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1