MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	436-3022X
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported during an angioplasty procedure, the device allegedly had a device-device incompatibility.It was further reported that the device allegedly had a retraction failure.Reportedly, balloon and guidewire removed from the patient.There was no reported patient injury.
Event or Problem Description
It was reported during an angioplasty procedure, the device allegedly had a device-device incompatibility.It was further reported that, the device allegedly retraction failure.Reportedly, balloon and guidewire removed from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.There was no sheath returned and the device was returned in very poor condition and in two sections.There was a partial 0.018" guidewire returned within the device and it could not be removed during the evaluation.The inner was bunched and stretched along the length of the distal section of the device.Both the inner and the outer were broken.The distal tip was damaged where the guidewire within had been bent and there were some areas of bunching observed on the balloon.It is likely that user handling was responsible for this catheter damage.The result of the investigation is inconclusive for the reported retraction issue.The investigation was confirmed for the reported device incompatibility issue.The definitive root cause for the reported device incompatibility and retraction issues could not be determined based upon the available information received from the field communications and sample evaluation.Labeling review: the instructions for use for the savvy long product was reviewed and contains the following information relevant to the reported event: description: a 0.018" guidewire is recommended for use with the savvy long catheters.Precautions: carefully inspect the catheter prior to use to verify that the catheter has not been damaged during shipment and that its size , shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Directions for use: remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve while holding the catheter as close to the balloon as possible.Id an resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, the product should not be used.The catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.Deflation and withdrawal: deflate the balloon by drawing a vacuum with a 20ml or larger syringe.Gently withdraw the catheter.As the balloon exits the vessel, use a smooth, gentle, steady counterclockwise motion.If resistance is felt upon removal the balloon and the sheath should be removed together as a unit under fluoroscopic guidance, particularly is balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.H10: d4 (expiry date: 02/2022), g3.H11: h6 (method, result).H11: section a through f ¿ the information provide by bd represents all 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: SAVVY LONG OTW PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 11376910
• Report Number: 9616666-2021-00018
• Device Sequence Number: 17110112
• Product Code: LIT
• UDI-Device Identifier: 00801741133008
• UDI-Public: (01)00801741133008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

1 Device 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 Model Number: 436-3022X
• Device Catalogue Number: 436-3022X
• Device Lot Number: CMDQ0396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No