MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IPN000254

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)

Event Date 07/16/2018

Event Type  malfunction  

Event Description

Patient was in ccl (cardiac cath lab) holding room post-intraaortic balloon pump placement, while waiting for icu rn to call ccl rn for report.Blood noted in iabp arterial pressure line; iabp alarmed; blood quickly advanced in helium tubing.There was concern for balloon rupture given blood in line.Patient became hypoxic and hypotensive.He was emergently brought into the cath lab where balloon was removed and a new 40cc iabp was placed under fluoroscopy.Blood was noted inside first balloon but no evidence of tear or rupture seen.Patient received 1 unit of blood, as well as epinephrine and dopamine.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 7776833
• MDR Text Key: 116924445
• Report Number: 7776833
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: (01)00801902007247(17)200131(10)18F18B0012
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F18B0012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21900 DA
• Patient Weight: 63