MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SEL PLUS 150/5CM 45TIP; CATHETER, CONTINUOUS FLUSH

Model Number	606-S255FX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The product lot number was not reported.The product is not available for evaluation and testing.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
A report from the field indicated that a vasospasm occurred during use of a prowler select plus 150/5cm 45tip (606s255fx/unknown lot #) microcatheter in an endovascular coil embolization of the right internal mammary artery.The physician aborted the delivery of the prowler select plus microcatheter, and the unspecified coil was attempted to be delivered to another blood vessel.However, there was a strong resistance felt between the prowler select plus microcatheter and the coil.The microcatheter and concomitant coil were removed from the patient as a unit and inspected, but no visual anomalies were noted.The prowler select plus microcatheter was subsequently replaced with another prowler select plus microcatheter.The case was concluded with the embolization of four blood vessels with 24 coils.No further details were provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr is to include the additional event information received on 04-mar-2020.The additional event information resulted in a change in the reportability of this complaint.It was noted that the described event of arterial spasm no longer meets the required criteria for medical device reporting as the information states that intervention was not required to reverse the spasm.Therefore, no further reports will be forthcoming.Section b5: additional information received indicated that the vasospasm did not require intervention.The lot number of the prowler microcatheter associated with the vasospasm was 30296215.The size/brand/manufacturer coil that was used with the prowler is unknown.The target lesion was located at the internal thoracic artery and thyroid carotid artery.Reportedly, the devices were used according to the instructions for use (ifu) and the user had not applied excessive force at any time.No further information was provided.Section 1.Initial reporter phone: (b)(6).

• Brand Name: PROWLER SEL PLUS 150/5CM 45TIP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9780125
• Report Number: 1226348-2020-00016
• Device Sequence Number: 2650411
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: 10886704028857
• 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,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2020

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 Expiration Date: 08/31/2022
• Device Model Number: 606-S255FX
• Device Catalogue Number: 606S255FX
• Device Lot Number: 30296215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTAFILL18 5MM X 20CM; GALAXY G3 4MM X 12CM; PROWLER SEL PLUS 150/5CM 45TIP
• Outcome Attributed to Adverse Event: Life Threatening