MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT PLUS 150/15CM

Catalog Number	606S252
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Cerebral (1889)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product complaint #: (b)(4).Since the products were 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 the no lot number was provided by the customer.This is one of two products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2019-00914.(b)(4).
Event or Problem Description
This complaint is from a literature source.As reported in the literature publication entitled, ¿dissecting internal carotid aneurysm causing epistaxis : a case report.¿ an (b)(6) woman experienced epistaxis and suffered from hemorrhagic shock at her previous hospital.Head computed tomography (ct) images revealed a ruptured internal carotid aneurysm protruding into the onodi cell, the most posterior ethmoidal sinus, which extends superolaterally to the sphenoid sinus.Cerebral angiography demonstrated a multilobular-shaped dissecting aneurysm with a maximal diameter of 6.7 mm at the cavernous portion of the internal carotid artery (ica).Overlapping stenting was performed to prevent recanalization.However, a fatal subarachnoid hemorrhage occurred 2 days after the procedure due to the progression of the dissection to the intracranial.The anatomical characteristics of the ethmoidal sinus could be associated with the occurrence of epistaxis.

• Brand Name: PROWLER SELECT PLUS 150/15CM
• Common Device Name: PROWLER SELECT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8683656
• Report Number: 3008264254-2019-00549
• Device Sequence Number: 2103650
• Product Code: KRA
• UDI-Device Identifier: 10886704028819
• UDI-Public: 10886704028819
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 606S252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/10/2019
• 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: Death
• Patient Age: 89 YR