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

Catalog Number UNKPROWLERSELECT

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The product catalog and lot numbers are not available / not reported.The expiration date of the device is not known.Initial reporter facility name: (b)(6) medical center general hospital.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the product catalog and lot numbers of the device are not available / not reported.[conclusion]: the healthcare professional reported that the 4.0mm dia x 16mm with no tip enterprise®2 stent ((b)(4)) became stuck in the hub of the prowler select plus microcatheter (catalog/lot#: unknown).Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile prowler select plus microcatheter was returned contained in a pouch with the enterprise®2 stent stuck inside the hub.The device was visually inspected and was observed to be broken and in ripped condition at the tip section.An attempt was made to remove the enterprise stent component from the microcatheter; however, the stent could not be removed.Dimensional analysis: the outer diameter (od) of the microcatheter was measured.The inner diameter (id) could not be measured due to the stent component stuck inside the hub and the ripped condition at the catheter tip.The hub and distal ids could not be measured.The actual microcatheter od (45cm from the distal end) = 0.0350 inch; specification maximum: 0.0375 inch.The reported issue documented in the complaint that the enterprise stent became stuck in the hub of the microcatheter is confirmed.The observed broken and ripped condition of the returned microcatheter is likely due to excessive force during handling of the device.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Devices undergo 100% inspection at final assembly for the condition of the product.Thus, it is not likely that the prowler select plus microcatheter left the manufacturing facility with the damages as observed on the returned device.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 that the 4.0mm dia x 16mm with no tip enterprise®2 stent ((b)(4)) became stuck in the hub of the prowler select plus microcatheter (catalog/lot#: unknown).Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The complaint device was returned for evaluation.During the visual / microscopic inspection of the returned device, device was observed broken and ripped at the tip section.Based on the product analysis 12/15/2020, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: UNKPROWLERSELECT
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11016733
• MDR Text Key: 229590176
• Report Number: 1226348-2020-00479
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKPROWLERSELECT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1