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

Model Number	N/A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during an angioplasty procedure the balloon was inflated (approx.15 atm).Negative pressure was then applied via inflation device prior to removal of the balloon, but the balloon would not deflate.They attempted to deflate the balloon for several minutes but it would not entirely deflate.The physician then removed the sheath and balloon, still not entirely deflated, as one unit.Procedure ended with patient not receiving optimal treatment with regard to the balloon not working correctly.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.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, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One advance 35 lp low profile balloon catheter was returned and examined.Inflation/deflation could not be performed due to possible occlusion.White flakes noted inside balloon.The white flakes are a result of contrast medium.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 would contribute to this failure mode.There were no other reported complaints for this lot number.It is plausible that the occlusion is a result of dried contrast medium injected into the balloon during the procedure.Therefore, it is also plausible the product was functioning at the start of the procedure and had been inflated and therefore became occluded during the procedure.Based upon the information provided and the characteristics displayed, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
Recoil of the patient's stenosis was reported in relation to this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Corrected data: report date: omitted on follow-up 1.

• 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: 6200327
• Report Number: 1820334-2016-01615
• Device Sequence Number: 13676274
• Product Code: DQY
• UDI-Device Identifier: 10827002522654
• UDI-Public: (01)10827002522654(17)190513(10)6970425
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2017

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: PTA5-35-135-6-4.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 05/26/2017; 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 DA