MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 8 FR - 40 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-S840C

Device Problem Physical Resistance (2578)

Patient Problems Hemorrhage, Subdural (1894); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

It was reported that while in the cath lab, the md prepared the catheter and inserted it according to the instructions for use.However, during insertion, excessive resistance was met.The md couldn't perform the insertion smoothly so that another kit was opened and replaced.There was no reported pt death, injury or complications.There was a delay / interruption in iabp therapy listed as less than 30 minutes.Medical / surgical intervention was not required.The pt outcome is stable.

Manufacturer Narrative

Qn # (b)(4).

• Brand Name: IAB: 8 FR - 40 CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4644651
• MDR Text Key: 5600086
• Report Number: 1219856-2015-00069
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F14E0032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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
• Patient Age: 62 YR
• Patient Weight: 65