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

Model Number	SPL25015X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Chest Pain (1776); Patient Problem/Medical Problem (2688)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient presented with acs, crushing chest pain and st elevation.One sprinter legend ptca balloon catheter was attempted to be used to treat a lesion in the proximal circumflex (cx) artery with mild tortuosity and calcification and 95% stenosis.There were no abnormalities reported in relation to patient's anatomy.There was no damage to the packaging.There were no issues noted when removing the devices from the hoop/tray.The devices were inspected with no issues.Negative prep was performed with no issues.No resistance was noted while advancing the balloon.The device was not moved or repositioned in the lesion.There was no inflation difficulty.It was reported that the balloon failed to deflate at the lesion site, after first inflation.An attempt was made to perforate the balloon with a stiff wire.A guideliner was then used to partially pull the balloon back into the guideliner and all was removed.The patient experienced some chest discomfort during the event but it subsided once the balloon was removed.The whole event lasted approx.10 minutes.The patient is alive with no injury.
Additional Manufacturer Narrative
Product analysis: the sprinter legend device and a guideliner returned loaded into a launcher guide catheter.The luer was detached and did not return for analysis.It was not possible to remove the device and the guideliner from the launcher.It was placed in a waterbath in order to aid removal from the launcher.Resistance was evident when attempting to remove the device from the launcher, the device would recoil back into the launcher.It appeared that a detachment occurred within the launcher.The launcher was dissected longitudinally in order to remove the detached device.It was evident from cutting the launcher that the braid wires of the body of the launcher were frayed and tangled around the guide liner and.There was severe stretching to the distal shaft possibly caused by the attempted removal of the device.Upon inspection after removal the marker bands were in correct position on the distal inner.The distal portion of the balloon appeared to have coiled inwards.It was not possible to perform deflation testing due to the condition of the returned device.Account confirmed luer would not be returning, cannot verify lot number through luer scan.Will confirm based on ed and returned device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the sprinter legend device and guideliner returned loaded into launcher.The luer of the sprinter legend was detached and did not return for analysis.It was not possible to remove device and guideliner from the launcher.It was placed in waterbath in order to aid removal from the launcher.Resistance was evident when attempting to remove the device from the launcher, the device would recoil back into the launcher.A detachment occurred within the launcher.The launcher was dissected longitudinally in order to remove the detached device.It was evident from cutting the launcher that the guideliner wire is twisted/coiled around the sprinter legend device.There was severe stretching to the distal shaft of the sprinter legend possibly caused by the attempted removal of the device.Upon inspection after removal, the marker bands were in correct position on the distal inner however the inner member had been pulled proximally.The balloon bond appeared stretched.The catheter tip and a portion of the balloon appeared to have folded inside.It was not possible to perform deflation testing due to the condition of the returned device.If information is provided in the future, a supplemental report will be issued.

• 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: 7661850
• Report Number: 9612164-2018-01604
• Device Sequence Number: 2355095
• Product Code: LOX
• UDI-Device Identifier: 00613994902597
• UDI-Public: 00613994902597
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 01/10/2019

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: 09/13/2020
• Device Model Number: SPL25015X
• Device Catalogue Number: SPL25015X
• Device Lot Number: 214020123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 12/14/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 11/01/2018; 01/10/2019
• 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: 58 YR
• Patient Weight: 70