MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-170-4-20
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that when the user opened the package to a advance 14 lp low profile balloon catheter device, they found "fluff" on the surface of the balloon portion.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 advance 14 lp low profile balloon catheter was returned in opened, unused condition.A single clear fiber was visible on the surface of the balloon.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 package seals (end seals, side seals, and chevron seal if applicable).Examine each seal for defects, foreign matter (dirt, hair, paper, fuzz, etc.).Ensure each seal is completely solid, smooth, and free from wrinkles.Seals must not be in the thumb notch.Product or inner pouch must not be caught in the seal.Examine entire package for defects.Product must be free of any visible cuts, holes, or foreign matter (dirt, hair, paper, fuzz, etc.)." based on the information provided, examination of the returned product, and the results of our investigation, the root cause for the foreign matter was determined to be related to manufacturing.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
Per email received 28 dec 2017: "the word ¿fluff¿ here means unknown fabric, i don¿t know how to describe it.".

• Brand Name: ADVANCE 14 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: 7155330
• Report Number: 1820334-2017-04579
• Device Sequence Number: 63459
• Product Code: DQY
• UDI-Device Identifier: 10827002503400
• UDI-Public: (01)10827002503400(17)200911(10)NS8206551
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: PTAX4-14-170-4-20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1