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

Catalog Number	PTA4-18-135-5-4
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Thrombus (2101); No Code Available (3191)
Date of Event	05/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a right femoral angioplasty procedure, femoral puncture was conducted from the ipsilateral approach (right).The physician reported difficult puncture due to body habitus.A 4fr short introducer was in situ.Focal calcified lesions noted on initial imaging through sfa.0.014" wire (another manufacturer) was used to cross lesions.Primary dilation with 4mm balloon (cook pta4).Secondary dilation with 5mm pta4 balloon.Balloon seen to rupture during plasty of lesion in mid sfa area.Maximum pressure used of 10atm.A small amount of contrast was seen to remain within the ruptured balloon.Negative pressure applied with inflation device to promote complete deflation of balloon.Balloon withdrawn over guide wire until resistance felt when balloon reached proximal sfa.Physician reports applying additional tension at this point as he felt that the balloon was partially withdrawn into femoral access sheath and was planning to withdraw both the ruptured balloon and the access sheath together.The physician reports feeling the resistance on the balloon suddenly give.On examination of withdrawn sheath and balloon, the distal tip of balloon catheter was missing.Under fluoroscopy, distal (detached) tip of balloon catheter identified in proximal sfa.(imaging shows the two balloon markers almost on top of one another as though concertinaed).Contra-lateral puncture made - additional wire passed through right sfa and zptx stent placed to fix balloon fragment against wall of vessel.Further filling defects then noted more distally in sfa thrombus balloon material.Further stents used through length of sfa (physician reports that sfa stenting was original plan).Post stenting, physician reports patent sfa, but thrombus noted in distal pt vessel.Attempt made to aspirate; however, no bleedback at all noted.Physician reports that repeat angiography then demonstrated occluded popliteal artery, likely due to thrombus shower from initial thrombus generation due to retained balloon catheter.The patient required 60 hours thrombolysis to achieve patency.A stent was used to fix the ruptured portion of the angioplasty balloon segment against the vessel wall.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Evaluation- a review of the complaint history, device history record, instructions for use (ifu), quality control (qc), specifications and visual inspection of the complaint device was conducted for the purpose of this investigation.The affected device was returned to aid in the investigation.The returned portion of the catheter measures 131.8 cm in length with 0.8cm of balloon intact.The balloon shows evidence of linear and circumferential tearing.Qc instructions are in place to verify that the device was manufacture to specifications.There is no evidence to suggest the device was not manufactured to specifications.Each device is shipped with ifu which states the appropriate uses, contraindications, warnings and precautions, and proper usage procedures including proper inflation and deflation procedures.The ifu states: do not exceed rated burst pressure and do not use a power injector for balloon inflation or injection of contrast medium as rupture may occur.The ifu also states, if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.The nominal inflation for this device is 8 atm and the rated burst pressure is 14 atm.The balloon was reported to be inflated to 10 atm, therefore over-inflation is not suspected to have caused the balloon to burst.It is unknown if the physician removed the balloon and sheath as a unit.It is noted that calcification was present.The device is designed to burst linearly.However, a balloon may burst or tear circumferentially due to angulation or calcification.Calcifications can have unexpected sharp protrusions which can damage the balloon and contribute to burst or tear.It is likely that calcification contributed to the failure mode, however, without objective evidence the root cause of this complaint is inconclusive.
Event or Problem Description
During a right femoral angioplasty procedure, femoral puncture was conducted from the ipsilateral approach (right).The physician reported difficult puncture due to body habitus.A 4fr short introducer was in situ.Focal calcified lesions noted on initial imaging through sfa.0.014" wire (another manufacturer) was used to cross lesions.Primary dilation with 4mm balloon (cook pta4).Secondary dilation with 5mm pta4 balloon.Balloon seen to rupture during plasty of lesion in mid sfa area.Maximum pressure used of 10atm.A small amount of contrast was seen to remain within the ruptured balloon.Negative pressure applied with inflation device to promote complete deflation of balloon.Balloon withdrawn over guide wire until resistance felt when balloon reached proximal sfa.Physician reports applying additional tension at this point as he felt that the balloon was partially withdrawn into femoral access sheath and was planning to withdraw both the ruptured balloon and the access sheath together.The physician reports feeling the resistance on the balloon suddenly give.On examination of withdrawn sheath and balloon, the distal tip of balloon catheter was missing.Under fluoroscopy, distal (detached) tip of balloon catheter identified in proximal sfa.(imaging shows the two balloon markers almost on top of one another as though concertinaed).Contra-lateral puncture made - additional wire passed through right sfa and zptx stent placed to fix balloon fragment against wall of vessel.Further filling defects then noted more distally in sfa thrombus balloon material.Further stents used through length of sfa (physician reports that sfa stenting was original plan).Post stenting, physician reports patent sfa, but thrombus noted in distal pt vessel.Attempt made to aspirate; however, no bleedback at all noted.Physician reports that repeat angiography then demonstrated occluded popliteal artery, likely due to thrombus shower from initial thrombus generation due to retained balloon catheter.The patient required 60 hours thrombolysis to achieve patency.A stent was used to fix the ruptured portion of the angioplasty balloon segment against the vessel wall.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5751490
• Report Number: 1820334-2016-00518
• Device Sequence Number: 19069100
• Product Code: DQY
• UDI-Device Identifier: 10827002502373
• UDI-Public: (01)10827002502373(17)170915(10)5283604
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K073378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PTA4-18-135-5-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/26/2016
• Device Age: 21 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2016
• Supplement Report FDA Received Date: 08/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR