MAUDE Adverse Event Report: KANEKA CORPORATION CROSPERIO RX; PTA BALLOON DILATATION CATHETER

Catalog Number	BD-B20200LR
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the concerned balloon catheter used was not returned to the manufacturer for investigation, the dhr with lot no.Sp036158 was reviewed and no nonconformity or abnormality in the manufacturing process was found.The lot passed all inprocess inspections including the balloon folded-shape check, the guidewire lumen integrity test and the shaft-pressurized test for every product and the finished product inspections including the balloon-repetitive inflation/deflation test and the shaft tensile strength test on representative samples based on the sampling plan.The balloon portion of crosperio rx is protected with a balloon protective tube inserted over the balloon and a stylet inserted into the guidewire lumen, and the stylet and the balloon protective tube are instructed to be removed before use.As mentioned above, it is obvious that the 5th crosperio rx was inserted into the patient's vessel with the balloon protective tube unremoved, hence the balloon could not be inflated, and the balloon protective tube came off while the catheter was pulled back and remained in the patient's vessel.We determined that the reported event was caused by not a defect or malfunction of the device but by a device handling issue.
Event or Problem Description
The dr.Was performing a lower extremity intervention utilizing several pta balloons.He used 4 crosperio rx pta balloon catheters without problems.Then, at one point, he was unable to inflate a 2mm x 200mm crosperio rx in the patient's anterior tibial artery.Upon closer examination via vascular ultrasound, the dr.Identified a foreign object in the patient's anterior tibial artery.It was very difficult to see during imaging; there were no markers, braiding etc.Post case, the dr.Reported that the scrub tech removed the stylet, but did not remove the balloon protective tube on one of the pta balloon.The scrub tech inserted the pta balloon (with the balloon protective tube still in place) over the guidewire and the dr.Advanced it into the 5fr introducer sheath.He was unable to inflate the pta balloon, so it was withdrawn.The balloon protective tube must have come off the balloon, dislodging in the patient's anterior tibial artery.Multiple attempts were made to remove the balloon protective tube, but were unsuccessful in this case.

• Brand Name: CROSPERIO RX
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18 nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 6203734
• Report Number: 9614654-2016-00015
• Device Sequence Number: 16213215
• Product Code: LIT
• UDI-Device Identifier: 04540778163430
• UDI-Public: 04540778163430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: BD-B20200LR
• Device Lot Number: SP036158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2016
• Initial Report FDA Received Date: 12/25/2016
• 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: INTRODUCER SHEATH:SIZE 5FR
• Outcome Attributed to Adverse Event: Other