MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G50260
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
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 the an advance 18 lp low profile balloon catheter ruptured (refer to this report).Additionally, the physician reported three other occurrences where advance 18 lp low profile balloon catheters (lots unknown), have ruptured (refer to medwatch: 1820334-2018-01601).No further information was provided.No adverse events have been reported.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
The customer confirmed that, during an "angio" [sic] of the superficial femoral artery, after access was obtained and the balloon was advanced to the site of inflation, the inflated balloon ruptured longitudinally at a pressure of 12 atmospheres (atm).The customer confirmed that the vessel was neither tortuous nor particularly calcified, although the calcification was characterized as minimal.The procedure was completed successfully using another balloon device.Visipaque contrast was employed with saline, with a 40/60 ratio employed.There was no angulation.Concomitant products: v18 wire (boston scientific), encore inflation handle (boston scientific), 5 french sheath (terumo).Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the complaint device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a longitudinal balloon rupture.The rupture was measured to begin a distance of 0.6 cm from the proximal marker band, and it extended to a length of 2.9 cm from the distal tip of the device.Both marker bands were present, as was the distal tip of the catheter.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 one nonconforming event which could contribute to this failure mode.However, due to the individual nature of the product manufacturing and 100% verification of various defects in final quality control prior to shipping, there is no indication that there is nonconforming product in the field.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.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 18 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: 7569150
• Report Number: 1820334-2018-01545
• Device Sequence Number: 13948053
• Product Code: DQY
• UDI-Device Identifier: 10827002502601
• UDI-Public: (01)10827002502601(17)191228(10)7549201
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K073378
• 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
• Report Date (Section B): 06/26/2018

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: G50260
• Device Catalogue Number: PTA4-18-80-7-8
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1