MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Catalog Number 606SXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported a patient underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of a basilar tip aneurysm and experienced thromboembolism during the procedure.Information regarding clinical symptoms is not known.The treating physician commented that small thrombi were ¿flying¿ into the periphery; the small thrombi may have flown due to the pulserider device being taken in and out several times during placement.The procedure details are as following: continuous flush was maintained.The pulserider 10t, 3.5 ¿ 4.5mm anrd ( (b)(4)) was implanted via a prowler select plus microcatheter (unk product code / unk lot number).An sl-10® microcatheter (stryker) was inserted into the aneurysm via transcell technique and coil embolization was performed.The pulserider anrd remains implanted and is thus not available for evaluation.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Based on the information provided, the actual severity of the reported event is unknown.Furthermore, the relationship of the pulserider anrd and the prowler select plus microcatheter to the reported event cannot be excluded.Thus, the event will be conservatively reported to the fda with the classification of ¿serious injury.¿ as part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00276 and 3008114965-2022-00277.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported a patient underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of a basilar tip aneurysm and experienced thromboembolism during the procedure.Information regarding clinical symptoms is not known.The treating physician commented that small thrombi were ¿flying¿ into the periphery; the small thrombi may have flown due to the pulserider device being taken in and out several times during placement.The procedure details are as following: continuous flush was maintained.The pulserider 10t, 3.5 ¿ 4.5mm anrd ( (b)(4)) was implanted via a prowler select plus microcatheter (unk product code / unk lot number).An sl-10® microcatheter (stryker) was inserted into the aneurysm via transcell technique and coil embolization was performed.The pulserider anrd remains implanted and is thus not available for evaluation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 25-apr-2022.[additional information]: on 25-apr-2022, limited additional information was received.The information indicated that there were no malfunctions or performance issues with respect to the pulserider device during the procedure.Information related to the prowler select plus microcatheter could not be obtained.E.1: initial reporter phone: (b)(6).This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00276 and 3008114965-2022-00277.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14194334
• MDR Text Key: 289988952
• Report Number: 3008114965-2022-00277
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 606SXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PULSERIDER T, 4MM, 10MM ARCH; SL-10® MICROCATHETER (STRYKER)
• Patient Outcome(s): Life Threatening