MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK OTW PTA CATHETER; PTA DILATATION CATHETER

Model Number	426-3022X
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that the pta dilation catheter allegedly could not pass the long and heavy stenosis anterior tibial artery (ata) lesion.Reportedly, immediately after the infrapopliteal percutaneous transluminal angioplasty (ip-pta), allegedly there was arterial perforation and excessive blood loss.Furthermore, the perforation was treated with a prolonged balloon tamponade.The current patient status is unknown.
Additional Manufacturer Narrative
Manufacturing review: the production history for the device, lot number 50128521, released on the 08th of september 15, 54 acceptable devices were reviewed and no anomalies were identified.The lot met all test release criteria.Nothing was found to indicate a manufacturing related cause for this event.Investigation summary: the result of the investigation is unconfirmed for the reported failure to advance issue.There was no kink or tip damage noted on the device.A 0.014" guidewire successfully passed through the device without issue.The definitive root cause for the reported failure to advance issue could not be determined based upon available information.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.It is possible that patient factors (long and heavy stenosis ata lesion) was the contributory factor in the reported event.It is unknown whether handling or procedural techniques contributed to the reported event.Labeling review: the ifu for the sleek otw product was reviewed and contains the following information relevant to the reported event: description: the sleek® otw percutaneous transluminal angioplasty (pta) peripheral catheter family are a non-reusable coaxial design catheter with a semicompliant balloon mounted on its distal tip.A 0.014¿ (0.356 mm) guidewire is recommended for use with the sleek® otw catheter.Warnings: to reduce the potential for vessel damage the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.Precautions: if resistance is felt upon removal, then the balloon, guidewire and the sheath/guide catheter should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath/guide catheter as a unit and withdrawing both together, using a gently twisting motion combined with traction.Before removing catheter from sheath/guide catheter it is very important that the balloon is completely deflated.Adverse effects: vessel perforation.
Event or Problem Description
It was reported that the pta dilation catheter allegedly could not pass the long and heavy stenosis anterior tibial artery (ata) lesion.Reportedly, immediately after the infrapopliteal percutaneous transluminal angioplasty (ip-pta), allegedly there was arterial perforation and excessive blood loss.Furthermore, the perforation was treated with a prolonged balloon tamponade.The current patient status is unknown.
Event or Problem Description
It was reported that the pta dilation catheter allegedly could not pass the long and heavy stenosis anterior tibial artery (ata) lesion.There was no reported patient injury.
Additional Manufacturer Narrative
H10: this supplemental emdr is being submitted to report additional information was provided.A new cir was provided stating the pta dilatation catheter could not pass the long & heavy stenosis ata lesion.The event was reassessed and determined to be not mdr reportable.Although, this event is no longer mdr reportable, an initial emdr and supplemental emdr were already submitted.Therefore, this supplemental report is being submitted to document the change in reportability.H10: g4.H11: b1, b2, b5, h3, h6(method, results, conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: SLEEK OTW PTA CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8433911
• Report Number: 9616666-2019-00024
• Device Sequence Number: 1019251
• Product Code: DQY
• UDI-Device Identifier: 00801741133787
• UDI-Public: (01)00801741133787
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K102035
• 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,Followup
• Report Date (Section B): 07/16/2019

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 Model Number: 426-3022X
• Device Catalogue Number: 426-3022X
• Device Lot Number: 50128521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 06/24/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/21/2019; 07/16/2019
• 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: Life Threatening