MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC UNKPROWLERSELECT; CATHETER, CONTINUOUS FLUSH

Catalog Number UNKPROWLERSELECT

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

Patient Problem Infarction, Cerebral (1771)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.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.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿bilateral thalamic stroke after tonsillectomy in a patient with collateral extracranial anastomosis ¿ case report¿ (pmid: 31019605).A (b)(6)-year-old patient with 6-mm pseudoaneurysm of the left facial artery in the tonsillar fossa who underwent endovascular embolization with a platinum detachable coil and a prowler 10 microcatheter experienced ischemic stroke on the next day after procedure.The patient was treated neurologically for stroke.Due to anemia associated with recurrent bleeding, a total of 6 u of packed red blood cells were transfused.The patient was discharged home 26 days later with improved cognitive and motor functions, with slight left-sided hemiparesis.The aim of this study to report an unusual case of a patient with recurrent post-tonsillectomy haemorrhage due to pseudoaneurysm of the facial artery, which persisted after eca ligation because of the presence of collateral occipital-vertebral anastomosis.Due to the recurrence of bleeding episodes, endovascular treatment was implemented.However, the embolization was complicated by bilateral thalamic stroke with unclear mechanism.Method: the trunk of the external carotid artery (eca) was selectively catheterized with a prowler 10 microcatheter (codman, raynham, u.S) via the anastomosis and subsequent embolization with a platinum detachable coil (target, stryker, fremont, u.S.) was accomplished.To achieve more complete embolization, n-butyl-2-cyanoacrylate (nbca) was injected via a magic 1.2f microcatheter cerenovus device was used in this study.No device specific information (including catalog and lot number) were provided in the article.Concomitant products: detachable coil target, unknown n-butyl-2-cyanoacrylate, microcatheter magic.

Manufacturer Narrative

Udi - (b)(4).Complaint sample was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.

• Brand Name: UNKPROWLERSELECT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9567071
• MDR Text Key: 189443686
• Report Number: 1226348-2020-00003
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKPROWLERSELECT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR