MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number	SPL12515X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the inner member, balloon and distal tip were detached from the delivery system and was entrapped on the guidewire.It was not possible to remove the detached section from the guidewire.The guidewire was measured and confirmed to be 0.014 inch.The balloon material appeared bunched.Severe stretching was evident to the inner member.Distal tip appeared stretched and deformed.The inner member appeared torn and uneven at the detachment location.There was no other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the procedure an attempt was made to use a sprinter legend rx ptca balloon catheter to treat a heavily calcified lesion in the lad.There was no damage noted to the packaging or any issues noted when removing from the hoop.The guide wire was examined and flushed before use with no issues noted.The sprinter legend balloon was inspected prior to use.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.Excessive force was not used during delivery.On first inflation, the balloon was inflated to 14 atm and got stuck on the 0.014"x300 cm non-medtronic guidewire.It was reported that the device was unable to be removed from the guide wire.The sprinter legend and the guidewire were removed together from the patient.It was informed that the balloon came off the wire.No patient injury was reported.Analysis of the returned device revealed the inner member, balloon and tip had detached from the delivery system and were entrapped on the guide wire.

• Brand Name: SPRINTER LEGEND RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8779978
• Report Number: 9612164-2019-02814
• Device Sequence Number: 16647767
• Product Code: LOX
• UDI-Device Identifier: 00643169271777
• UDI-Public: 00643169271777
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K103095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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 Expiration Date: 09/12/2021
• Device Catalogue Number: SPL12515X
• Device Lot Number: 216206098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 107