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

Model Number	G52360
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation = non-healthcare professional.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
As reported, during angioplasty of a dialysis fistula graft involving a (b)(6) year-old male patient, an advance 35 lp low profile balloon catheter ruptured circumferentially below burst pressure and separated.The lesion/stenosis, located in the mid-humerus, was reported to be "tight" and the anatomy was tortuous, described as a bell-shaped curve.Calcification was reported; however, significant calcification was not noted.Another manufacturer's six french sheath was used during the procedure as well as another manufacturer's inflation device and a cook uniglide "rr" 0.035 inch guide wire.Visipaque contrast was used, with a believed ratio of 40/60, to inflate the device one time.The device ruptured below eleven atmospheres.Blood was not noted in the inflation device and the balloon was not inflated inside a stent prior to rupture.The proximal portion of the device was removed with the sheath; however, the distal portion of the device remained in the patient.An open thrombectomy is planned to remove the separated portion from the patient, but has yet to be performed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Additional information was received on (b)(6) 2019 noting that the remainder of the distal portion of the complaint device was successfully retrieved.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.Investigation ¿ evaluation.Reviews of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that both sections of the correct device was received for investigation.Both pieces had visible biomatter present.For the proximal segment, the catheter shaft had separated between what would be the two balloon bonds and was elongated, visibly noted by the color change and diameter reduction.What appeared to be a 6 fr.Sheath was on the catheter shaft.The sheath was able to be moved freely.However, this device is meant to be used with a 5 fr.Sheath so the accompanying sheath was the incorrect size.One marker band was present but not secure.The separation point of the balloon material was consistent with circumferential tearing.Ridges at the distal end of the balloon material were noted and appeared to be damage inflicted while removing the device.The shaft extended past the end of the balloon material.The length of the balloon catheter was noted to be within required specifications but was not consistent with an undamaged catheter shaft because of the separation and elongation.The distal segment, distal tip of the catheter appeared to have indentations which were believed to be from a medical instruction, such as forceps.The balloon catheter shaft, beneath the balloon material appeared elongated and did not extend past eh balloon material.The distal marker band was noted on catheter shaft but was not secure.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.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states that the device is indicated for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries; including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral; and obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The document also instructs that if balloon pressure is lost and/or the balloon ruptures, deflate the balloon and sheath as a unit.Warnings on the packaging and instructions indicate to maintain a pressure below the rated burst pressure as rupture may occur.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 8795348
• Report Number: 1820334-2019-01700
• Device Sequence Number: 2043189
• Product Code: DQY
• UDI-Device Identifier: 10827002523606
• UDI-Public: (01)10827002523606(17)220222(10)9543752
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2022
• Device Model Number: G52360
• Device Catalogue Number: PTA5-35-80-8-6.0
• Device Lot Number: 9543752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO 6FR PINNACLE SHEATH, BARD INFLATION.; TERUMO 6FR PINNACLE SHEATH, BARD INFLATION
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR